Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

HYDRASYS ISO-LDH, ISO-PAL, CHOL… — IVDR Class A IVDR by sebia

MD Atlas
sebia

EUDAMED last updated this device on Jul 19, 2022

HYDRASYS ISO-LDH, ISO-PAL, CHOL ACCESSORIES

3607361261BUC2

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: sebia
UDI-DI code: 03607360012611
Reference / catalog number: 1261

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: sebia
SRN: FR-MF-000003520
Manufacturer status: Active

Related devices

"AUTOMATIC LOW VOLUME" LABELS FOR MINICAP FLEX-PIERCING (20)3607369208BUF3On the market "MANUAL LOW VOLUME" LABELS FOR MINICAP FLEX-PIERCING (20)3607369209BUF8On the market 15 WELLS ANTISERA SEGMENT (10)3607364397BUF7On the market 18 WELLS ANTISERA SEGMENT (10)3607364398BUFCOn the market A1C/CE - CAPILLARY BLOOD SAMPLE KIT (A)3607369212BUECOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: HYDRASYS ISO-LDH, ISO-PAL, CHOL ACCESSORIES
UDI-DI code: 03607360012611
Basic UDI-DI: 3607361261BUC2
Reference / catalog number: 1261
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Accessory
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W020105019099VARIOUS ELECTROPHORESIS INTRUMENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification